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BLA

TEBENTAFUSP-TEBN | B761228 | IMMUNOCORE LTD

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

January 25, 2034(2763 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 25, 2034	Active	Computed
7-Year Orphan	Jan. 25, 2029	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761228

351(a) ReferenceLicensedCDERInjection

Proper Name

tebentafusp-tebn

Applicant

Immunocore Limited

Approval Date

25-Jan-22

Orphan Exclusivity

25-Jan-29

2y 6mo remaining

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MCG/0.5ML

▴

INJECTABLE;INJECTION | Approved: 2022-01-25 00:00:00

No patent or exclusivity listings for this strength.